Evidence map›Paper›PMID 25820046›Full record

Observational studyIndian heart journal

Observational study to evaluate the safety and efficacy of saroglitazar in Indian diabetic dyslipidemia patients.

Sadanand R Shetty, Soumitra Kumar, R P Mathur, Kamal H Sharma, Ashok D Jaiswal

Open access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Indian heart journal. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
4.7field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 42 citations in OpenAlex.

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  9. Unraveling the Potential Role ofInternational journal of molecular sciences · 2023
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  10. Current and Emerging Approaches for Hepatic Fibrosis Treatment.Gastroenterology research and practice · 2021
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 5 institutions in 1 country.

Sadanand R ShettyProfessor & Ex HOD, Department of Medicine, D.Y. Patil University, CMD, Sadanand Healthy Living Center, Mumbai, India.
Soumitra KumarProfessor (Cardiology), Department of Medicine, Vivekananda Institute of Medical Sciences, Kolkata, India.
R P MathurProfessor & HOD, Department of Endocrinology, Osmania Medical College, Hyderabad, India.
Kamal H SharmaAssociate Professor, UN Mehta Institute of Cardiology, BJ Medical College, Ahmedabad, India.
Ashok D JaiswalZydus Tower, Near Satellite Cross Road, Opposite Iscon Temple, Satellite, Ahmedabad, India. Electronic address: ashokd.jaiswal@zyduscadila.com.
B.J. Medical College · INCadila Healthcare (India) · IND.Y. Patil University · INOsmania Medical College · INVivekananda Institute of Medical Sciences · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledSaroglitazar is a dual PPAR α/γ agonist approved in India for the management of diabetic dyslipidemia.

aimsThe objective of this study was to evaluate the safety and efficacy of saroglitazar 4 mg once daily in clinical practice.

methodsThis was an observational, multicenter, single-arm study. Patients with type 2 diabetes (with on-going antidiabetic medication), age above 18 years, and triglycerides ≥200 mg/dL were included.

resultsA total 2804 patients with a mean duration of diabetes 6.29 yrs were included in this analysis. The baseline demographic profile was: mean age of 53 yrs, mean body weight 72.3 kg and mean BMI of 27 kg/m(2). 62.5% patients were male and 57.8% were reported to be on statin therapy at baseline. All 2804 patients were on antidiabetic medications with 15.4% patients on monotherapy and rest were on two or more than two antidiabetic medications at baseline. The baseline triglycerides and HbA1C values were 312.3 mg/dL and 8.3% respectively. At 3 months follow-up, use of saroglitazar 4 mg led to significant reduction in TG (35.8%), LDL-C (16.4%), total cholesterol (19%) and non-HDL-C (23.4%). Addition of saroglitazar to baseline antidiabetic medications showed a significant 0.9% absolute reduction in HbA1c with significant improvement in fasting and post prandial plasma glucose. No serious adverse events, alteration in liver or renal enzymes and edema or weight gain were reported.

conclusionSaroglitazar is a potential therapeutic option in type 2 diabetic patients with high TG levels, not controlled by statins, for comprehensive control of lipid and glycemic parameters with acceptable safety profile.

Indexed as

Blood GlucoseDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDrug Administration ScheduleDyslipidemiasFemaleFollow-Up StudiesHumansIndiaLipidsMaleMiddle AgedPhenylpropionatesPrevalencePyrrolesTreatment OutcomeBlood GlucoseLipidsPhenylpropionatesPyrrolessaroglitazarDiabetic dyslipidemiaPPARSaroglitazarTriglycerides

Identifiers

PMID25820046
PMCPMC4382542
OpenAlexW2112044211

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.